Experience in the use of the drug Tixagevimab / Cilgavimab in the complex therapy of coronavirus infection in the Primorsky territory

Abstract

BACKGROUND: Since the beginning of the coronavirus pandemic, various treatment options and regimens, and their combinations, have been used. However, before the start of vaccination and the introduction of biologic drugs and monoclonal antibodies, life-threatening complications occurred much more often.

AIM: To assess the efficacy and safety of Tixagevimab / Cilgavimab (“Evusheld”) for the treatment of patients with comorbidities and SARS-CoV-2 infection in comparison with standard therapy protocols in vaccinated and unvaccinated people.

MATERIALS AND METHODS: A retrospective study of the inpatient medical records of 290 patients with a confirmed diagnosis of moderate COVID-19 caused by SARS-CoV-2 was conducted.

RESULTS: The average bed-days in the three groups varied. The lowest number was recorded in the Tixagevimab / Cilgavimab group with 9.9 days. In the vaccinated and unvaccinated groups, the corresponding values were 10.9 and 11.7 days. The duration of the COVID-19 course was minimal in the Tixagevimab / Cilgavimab with 12.6 days; in the vaccinated and unvaccinated groups, the disease lasted an average of 17.6 and 18.7 days, respectively. The percentage of lung tissue damage was the highest in the unvaccinated group with 43.2% on average, followed by the vaccinated group with 26.5% and the Tixagevimab / Cilgavimab group with 4.3%. Moreover, 53.6%, 32.5%, and 13.6% of the unvaccinated, vaccinated, and Tixagevimab / Cilgavimab groups required oxygen support, respectively. In the unvaccinated group, leukocytosis increased to 11.3×10⁹, which was associated with the emergence of a bacterial infection and prolonged hospitalization.

CONCLUSIONS: The preparation of synthetic recombinant monoclonal neutralizing antibody Tixagevimab / Cilgavimab to SARS-CoV-2 significantly reduces the severity of COVID-19 and the first day of hospitalization.

Keywords

coronavirus infection / SARS-CoV-2 / COVID-19 / treatment / Tixagevimab / Cilgavimab

References

[1] Temporary guidelines. Prevention, diagnosis and treatment of a new coronavirus infection COVID-19. Version 16 (08.18.2022). Available from: https://static.edu.rosminzdrav.ru/fc0001/fdpo/decanat/NMO_MZ/TEOC/u9/VremMetRec/%D0%92%D0%9C%D0%A0_COVID-19_V16.pdf (In Russ.)

[2] Временные методические рекомендации. Профилактика, диагностика и лечение новой коронавирусной инфекции COVID-19. Версия 16 (18.08.2022). Режим доступа: https://static.edu.rosminzdrav.ru/fc0001/fdpo/decanat/NMO_MZ/TEOC/u9/VremMetRec/%D0%92%D0%9C%D0%A0_COVID-19_V16.pdf

[3] Drapkina OM, Berns SA, Gorshkov AYu, et al. Reactogenicity of various COVID-19 vaccination regimens. Cardiovascular Therapy and Prevention. 2022;21(12):3476. (In Russ.) doi: 10.15829/1728-8800-2022-3476

[4] Драпкина О.М., Бернс С.А., Горшков А.Ю., и др. Реактогенность различных схем вакцинации против COVID-19 // Кардиоваскулярная терапия и профилактика. 2022. Т. 21, № 12. С. 3476. doi: 10.15829/1728-8800-2022-3476

[5] Tzenios N, Chahine M, Tazanios M. Better Strategies for Coronavirus (COVID-19) Vaccination. Special Journal of the Medical Academy and Other Life Sciences. 2023;1(2). doi: 10.58676/sjmas.v1i2.11

[6] Tzenios N., Chahine M., Tazanios M. Better Strategies for Coronavirus (COVID-19) Vaccination // Special Journal of the Medical Academy and Other Life Sciences. 2023. Vol. 1, N 2. doi: 10.58676/sjmas.v1i2.11

[7] Fomina DS, Lebedkina MS, Markina UA, et al. SARS-CoV-2-neutralising monoclonal antibodies: mechanism of action and research results. Pediatria. Journal named after G.N. Speransky. 2022;101(3):156–169. (In Russ.) doi: 10.24110/0031-403X-2022-101-3-156-169

[8] Фомина Д.C., Лебедкина М.С., Маркина У.А., и др. Вируснейтрализующие моноклональные антитела при COVID-19: механизм действия и результаты исследований // Педиатрия. Журнал им. Г.Н. Сперанского. 2022. Т. 101, № 3. С. 156–169. doi: 10.24110/0031-403X-2022-101-3-156-169

[9] Benotmane I, Velay A, Gautier-Vargas G, et al. Pre-exposure prophylaxis with 300 mg Evusheld elicits limited neutralizing activity against the Omicron variant. Kidney International. 2022;102(2): 442–444. doi: 10.1016/j.kint.2022.05.008

[10] Benotmane I., Velay A., Gautier-Vargas G., et al. Pre-exposure prophylaxis with 300 mg Evusheld elicits limited neutralizing activity against the Omicron variant // Kidney International. 2022. Vo. 102, N 2. P. 442–444. doi: 10.1016/j.kint.2022.05.008

[11] Focosi D, Casadevall A. A Critical Analysis of the Use of Cilgavimab plus Tixagevimab Monoclonal Antibody Cocktail (Evusheld™) for COVID-19 Prophylaxis and Treatment. Viruses. 2022;14(9):1999. doi: 10.3390/v14091999

[12] Focosi D., Casadevall A. A Critical Analysis of the Use of Cilgavimab plus Tixagevimab Monoclonal Antibody Cocktail (Evusheld™) for COVID-19 Prophylaxis and Treatment // Viruses. 2022. Vol. 14, N 9. P. 1999. doi: 10.3390/v14091999

[13] Pryshchepenka VA, Yupatau HI, Okulich VK. Prognostication of the severe disease course in patients with viral pneumonia presumably caused by COVID-19. Vestnik Vitebskogo Gosudarstvennogo Meditsinskogo Universiteta. 2020;19(3):69–78. (In Russ.) doi: 10.22263/2312-4156.2020.3.69

[14] Прищепенко В.А., Юпатов Г.И., Окулич В.К. Прогнозирование тяжёлого течения заболевания у пациентов с вирусными пневмониями, предположительно вызванными COVID-19 // Вестник Витебского государственного медицинского университета. 2020. Т. 19, № 3. С. 69–78. doi: 10.22263/2312-4156.2020.3.69

[15] Grinevich VB, Gubonina IV, Doshchitsin VL, et al. Management of patients with comorbidity during novel coronavirus (COVID-19) pandemic. National Consensus Statement 2020. Cardiovascular Therapy and Prevention. 2020;19(4):2630. (In Russ.) doi: 10.15829/1728-8800-2020-2630

[16] Гриневич В.Б., Губонина И.В., Дощицин В.Л., и др. Особенности ведения коморбидных пациентов в период пандемии новой коронавирусной инфекции (COVID-19). Национальный Консенсус 2020 // Кардиоваскулярная терапия и профилактика. 2020. Т. 19, № 4. С. 2630. doi: 10.15829/1728-8800-2020-2630

[17] Gassan MV, Sedinina AS. Vaccine against COVID-19. In: Science in the modern world. Collection of scientific papers based on the materials of the 20th International Scientific and Practical Conference. Anapa: Izd-vo «NITs ESP» v YuFO; 2021. P. 47–51. (In Russ.)

[18] Гассан М.В., Сединина А.С. Вакцина от COVID-19. В кн.: Наука в современном мире. Сборник научных трудов по материалам XX Международной научно-практической конференции. Анапа: Изд-во «НИЦ ЭСП» в ЮФО, 2021. С. 47–51.

[19] Nadtocheeva V, Bulanov N, Akulkina L. Outcomes of breakthrough COVID-19 in hospitalized adult patients vaccinated with Gam-COVID-Vac (Sputnik V). Klinicheskaya farmakologiya i terapiya = Clin Pharmacol Ther. 2022;31(2):20–26 (In Russ.) doi: 10.32756/0869-5490-2022-2-20-26

[20] Надточеева В.Б., Буланов Н.М., Акулкина Л.А., и др. Эффективность вакцины Гам-КОВИД-Вак (Спутник V) в профилактике тяжёлого течения COVID-19 и смерти у госпитализированных взрослых пациентов // Клиническая фармакология и терапия. 2022. Т. 31, № 2. С. 20–26. doi: 10.32756/0869-5490-2022-2-20-26

[21] Boschi C, Colson P, Bancod A, Moal V, La Scola B. Omicron Variant Escapes Therapeutic Monoclonal Antibodies (mAbs) Including Recently Released Evusheld®, Contrary to 8 Prior Main Variant of Concern (VOC). Clin Infect Dis. 2022;75(1):e534–e535. doi: 10.1093/cid/ciac143

[22] Boschi C., Colson P., Bancod A., Moal V., La Scola B. Omicron Variant Escapes Therapeutic Monoclonal Antibodies (mAbs) Including Recently Released Evusheld®, Contrary to 8 Prior Main Variant of Concern (VOC) // Clin Infect Dis. 2022. Vol. 75, N 1. P. e534–e535. doi: 10.1093/cid/ciac143

[23] Rogova IV, Zhidkova EA, Popova IA, Zaborovskiy AV, Gurevich KG. Pharmacoeconomic aspects of COVID-19 treatment. Farmakoekonomika. Modern Pharmacoeconomics and Pharmacoepidemiology. 2021;14(3):357–364. (In Russ.) doi: 10.17749/2070-4909/farmakoekonomika.2021.086

[24] Рогова И.В., Жидкова Е.А., Попова И.А., Заборовский А.В., Гуревич К.Г. Фармакоэкономические аспекты лечения COVID-19 // Фармакоэкономика. Современная фармакоэкономика и фармакоэпидемиология. 2021. Т. 14, № 3. С. 357–364. doi: 10.17749/2070-4909/farmakoekonomika.2021.086

[25] Avdeeva MG, Kulbuzheva MI, Zotov SV, Zhuravleva YeV, Yatsukova AV. Microbial landscape in hospital patients with new coronavirus disease (COVID-19), antibiotic resistance comparison vs. Pre-covid stage: a prospective study. Kuban Scientific Medical Bulletin. 2021;28(5):14–28. (In Russ.) doi: 10.25207/1608-6228-2021-28-5-14-28

[26] Авдеева М.Г., Кулбужева М.И., Зотов С.В., Журавлева Е.В., Яцукова А.В. Микробный пейзаж у госпитальных больных с новой коронавирусной инфекцией COVID-19, сравнительная антибиотикорезистентность с «доковидным» периодом: проспективное исследование // Кубанский научный медицинский вестник. 2021. Т. 28, № 5. С. 14–28. doi: 10.25207/1608-6228-2021-28-5-14-28

RIGHTS & PERMISSIONS

Eco-vector